Delta-9-tetrahydrocannabinol/Cannabidiol, THC/CBD (Sativex®) which is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
|05/12/2012||04/01/2013||Full Pharmacoeconomic Assessment Recommended|
|11/07/2014*||26/09/2014||Reimbursement Not Recommended|
*Formal assessment commenced following legislative changes.
The NCPE does not recommend reimbursement of Sativex® at the submitted price.
|NCPE Assessment Process||Complete|
|Rapid review commissioned||12/02/2018|
|Rapid review completed||03/04/2018|
|Rapid Review outcome||A full pharmacoeconomic assessment is recommended to assess the clinical effectiveness and cost effectiveness of Sativex® compared with the current standard of care.|
|Full pharmacoeconomic assessment commissioned by the HSE||20/04/2018|
|Pre-submission consultation with Applicant||25/09/2018|
|Submission received from Applicant||12/08/2019|
|Preliminary review sent to Applicant||10/02/2020|
|NCPE assessment re-commenced||01/12/2020|
|Preliminary review follow-up sent to Applicant||19/03/2021|
|NCPE assessment re-commenced||04/05/2021|
|Factual accuracy check sent to Applicant||08/06/2021|
|NCPE assessment re-commenced||21/06/2021|
|NCPE assessment completed||15/07/2021|
|NCPE assessment outcome||The NCPE recommends that Sativex® not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.|
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.